MyopiaNCT00813982

Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

A study testing Lotrafilcon A Experimental Contact Lens and Lotrafilcon A Commercial Contact Lens in people with Myopia, run by CIBA VISION.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Lotrafilcon A Experimental Contact Lens and Lotrafilcon A Commercial Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Nov 2008to Dec 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
Other protocol-defined inclusion/exclusion criteria may apply

Who cannot join

Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
Any active corneal infection
Any use of medications for which contact lens wear would be contraindicated
History of corneal refractive surgery
Wears toric contact lenses
Other protocol-defined inclusion/exclusion criteria may apply

About this study

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.

Conditions: Myopia
Being tested: Lotrafilcon A Experimental Contact Lens, Lotrafilcon A Commercial Contact Lens
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lotrafilcon A Experimental Contact LensDevice
Experimental spherical, silicone hydrogel soft contact lens
Lotrafilcon A Commercial Contact LensDevice
Commercially marketed spherical, silicone hydrogel soft contact lens

Study groups in NCT00813982
Study group	Role	What they receive
Experimental Lotrafilcon A Contact Lens	Experimental	Lotrafilcon A experimental contact lens randomly assigned to one eye Receives: Device: Lotrafilcon A Experimental Contact Lens
Commercial Lotrafilcon A Contact Lens	Active comparator	Lotrafilcon A commercial contact lens randomly assigned to one eye Receives: Device: Lotrafilcon A Commercial Contact Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Vision
Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Dec 2008

First posted23 Dec 2008 (estimated)
Study startNov 2008
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00813982
Sponsor's protocol ID: P-335-C-009
Status last verified: May 2023
First submitted: 22 Dec 2008
Last updated: 26 May 2023
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
ClinicalTrials.gov ID: NCT00813982
Acronym / sponsor ID: P-335-C-009
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 23 Dec 2008 (estimated)
Results: Posted 29 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Experimental Lotrafilcon A Contact Lens	Experimental	Device: Lotrafilcon A Experimental Contact LensLotrafilcon A experimental contact lens randomly assigned to one eye
Commercial Lotrafilcon A Contact Lens	Active comparator	Device: Lotrafilcon A Commercial Contact LensLotrafilcon A commercial contact lens randomly assigned to one eye

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
Other protocol-defined inclusion/exclusion criteria may apply

Key exclusion criteria (8 listed)

Requires concurrent ocular medication
Eye injury or surgery within twelve weeks immediately prior to enrollment
Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
Any active corneal infection
Any use of medications for which contact lens wear would be contraindicated

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lotrafilcon A Experimental Contact LensExperimental spherical, silicone hydrogel soft contact lens	Device	Experimental Lotrafilcon A Contact Lens
Lotrafilcon A Commercial Contact LensCommercially marketed spherical, silicone hydrogel soft contact lens	Device	Commercial Lotrafilcon A Contact Lens

Primary outcome

Overall Vision
Time frame: 1 week
Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Results and safety

Results posted to the registry on 29 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Contact Lens / Commercial Contact Lens	59	59

Primary outcome: Overall Vision

Time frame: 1 week. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Lotrafilcon A Commercial Contact Lens n = 56	Lotrafilcon A Experimental Contact Lens n = 56
Value	8.7 (1.5)	8.7 (1.7)

Population analysed: Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.

Adverse events

Time frame: 1 week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon A Commercial Contact Lens	0 of 59 (0%)	0 of 59 (0%)	Not reported
Lotrafilcon A Experimental Contact Lens	0 of 59 (0%)	0 of 59 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
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High Myopia, Intraocular Pressure
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon A Experimental Contact Lens and Lotrafilcon A Commercial Contact Lens in people with Myopia, run by CIBA VISION.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Vision (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00813982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.